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Make a difference in patients' lives one submission at a time! Rocket's Regulatory organization provides unmatched expertise related to global regulatory activities through all stages of a product's lifecycle and is at the forefront of shaping a dynamic regulatory landscape in GeneTherapy. Today's work at Rocket will create a roadmap for future gene therapy approvals in the years to come. Rocket's pipeline of first-in-class therapies and numerous expedited review designations yields more opportunities to interact with health authorities and build collaborative relationships. This dedicated organization features some of the best talent in the world and is guided by delivering curative gene and cell therapies for rare and devastating diseases. Open Roles: Vice President, Regulatory Affairs Sr. Director/Director, EU Regulatory Sr. Director/Director, Regulatory CMC Sr. Director/Director, Regulatory Affairs Associate Director/Director Global Labeling Lead Manager, Regulatory Manager, Regulatory Operations
Build. Test. Perfect. Execute. Repeat. Gene and cell therapy is about delivery. Creating, testing, fine-tuning, and perfecting a replicable process to manufacture vector and drug product at optimal genetic payloads can turn hope into reality for patients. At the heart of Rocketâs in-house manufacturing investment is not its 100,000 sq ft state-of-the-art facility, but the talented people building it, creating and nurturing the processes within, and scaling up to meet the needs of an expanding homegrown pipeline. The Rocket manufacturing team works with the end goal in mind: innovate to meet commercial needs â not the next cohort of patientsâ¦and itâs the only team in biotech doing it on both AAV and LV platforms.
Lay the Blueprint! The Rocket CMC Lentivirus Team envisions setting a high bar within the industry to enable more cell therapies to reach more patients, thereby improving more lives. The strong scientific minds come from varied backgrounds and geographies, notable for different training experiences and most importantly, ways of thinking. This diversity of thought helps the team transform bespoke ideas into smart execution. The team of builders is pioneering a blueprint for the future â the future of Rocket, the future of science, and the future of children with rare and devastating disorders.
Be an architect of world-class Quality! As the regulatory environment for cell and gene therapy continues to evolve, patients are counting on the culture and quality systems of developers to deliver safe and effective products. The Rocket Quality team is a pioneer in this territory, applying efficient, effective, and compliant approaches to support a growing pipeline of five active clinical programs using both AAV and LV platforms. In a new, state-of-the-art R&D and Manufacturing facility, the Quality organization works to develop and validate the latest analytical technologies while building and continually improving quality systems that serve a robust pipeline of curative gene and cell therapies.
Rocket Pharma is accepting applications for these #genetherapy #hotjobs: Associate Director, Clinical Sciences Vice President, Regulatory Affairs Sr. Director, Process Development - Gene Therapy Director, Quality Assurance Viral Vector Manufacturing Manager
Positive Data from Phase 1 Trial of RP-A501 for the Treatment of Danon Disease
Positive Clinical Data from Fanconi Anemia and Leukocyte Adhesion Deficiency-I Programs
FDA Clearance of IND for RP-L401 Gene Therapy for Infantile Malignant Osteopetrosis
Buildout of R&D and Manufacturing Facility
